FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K Number: K001747
·
Decision Jul 13, 2000
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
10
Review Days
35
Basic Information
- Device Name
- MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
- K Number
- K001747
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BARCO NV DISPLAY SYSTEMS
- Date Received
- June 8, 2000
- Decision Date
- July 13, 2000
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by BARCO NV DISPLAY SYSTEMS
| K Number | Device Name | ||
|---|---|---|---|
| K001748 | MEDIS 5MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM | Jul 27, 2000 | Substantially Equivalent |
| K001753 | MEDIS 5MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM | Jul 27, 2000 | Substantially Equivalent |
| K001750 | MEDIS 5MP1H QUAD-HEAD MEDICIAL DIAGNOSTIC DISPLAY SYSTEM | Jul 21, 2000 | Substantially Equivalent |
| K001751 | MEDIS 2MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM | Jul 19, 2000 | Substantially Equivalent |
| K001752 | MEDIS 55MP1H SINGLE-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM | Jul 19, 2000 | Substantially Equivalent |
| K001754 | MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM | Jul 19, 2000 | Substantially Equivalent |
| K982820 | BARCO MEDIS 5MP 5 MEGAPIXEL MEDICAL DIAGNOSTIC DISPLAY SYSTEM | Oct 8, 1998 | Substantially Equivalent |
| K980541 | BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY | Apr 9, 1998 | Substantially Equivalent |
| K972701 | BARCO MWD 321 MEDICAL WORKSTATION DISPLAY | Jan 2, 1998 | Substantially Equivalent |